Obstructive Sleep ApneaPhase 4NCT03467750

Effect of Ketorolac on Post Adenotonsillectomy Pain

A Phase 4 study testing Ketorolac in people with Obstructive Sleep Apnea, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 18 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Ketorolac
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 19 Jul 2018to 22 Aug 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Diagnosis of sleep disordered breathing or obstructive sleep apnea
Children undergoing elective tonsillectomy or adenotonsillectomy at Children's Healthcare of Atlanta Egleston location
Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Who cannot join

Known coagulation defect
Patients on longstanding NSAID therapy
Known renal impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Childrens Healthcare of Atlanta, Egleston
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Ketorolac as a Strategy for Reducing Post-operative Opioid Requirements in Children With Obstructive Sleep Apnea Undergoing Adenotonsillectomy: a Randomized Controlled Trial

This randomized prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with obstructive sleep apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study group where they will receive ketorolac in addition to the standard of care treatment or will receive only the standard of care pain management. The researchers hypothesize that by administering ketorolac at the end of the procedure once hemostasis has been achieved, it will be possible to decrease the amount of morphine administered in the post-anesthesia care unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy and safety of the current standard post-operative analgesic regimen employed at the study institution, in which opioid analgesia currently plays a prominent role.

Read the detailed description

Obstructive sleep apnea (OSA) as an indication for adenotonsillectomy has increased significantly over the past ten years, and now has surpassed recurrent tonsillitis as the most common indication for this procedure. Opioids continue to be the most commonly administered pain medication for these procedures. Studies have shown that patients with OSA have significantly increased sensitivity to opioids that results in post-operative respiratory depression and apnea when administered via standard opioid dosing protocols. Children with OSA were shown to have a nearly fivefold increase in the odds of developing respiratory complications when compared to their counterparts with tonsillitis. Ketorolac possesses similar efficacy to morphine without the problematic complications of respiratory depression, nausea and vomiting, which are commonly seen post-adenotonsillectomy. Importantly, when combined with opioids, ketorolac is opioid-sparing. This synergistic effect means that a similar level of analgesia is achieved using a lower dose of opioid. However, there continues to be concern about using ketorolac due to the potential risk of post-operative bleeding from anti-platelet activity.

This randomized, prospective study aims to determine the effect of ketorolac on the total dose of morphine required to achieve postoperative analgesia in children with OSA undergoing adenotonsillectomy. Participants will be randomly assigned to receive ketorolac or to not receive ketorolac. The post-anesthesia care unit (PACU) nurses, who will be blinded to ketorolac administration, will evaluate the patients using the Face, Legs, Activity, Cry, Consolability (FLACC) scale scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. For patients with a FLACC score of 6-10, morphine (0.05mg/kg) will be administered. For patients with FLACC scores of 3-5, morphine (0.025mg/kg) will be administered. The total amount of opioid required to obtain a FLACC score of less than 3 will be evaluated as the primary outcome. The secondary outcomes to be evaluated will be PACU FLACC scores, time required in PACU, incidence of post-tonsillectomy bleeding and total pain medications administered during hospital admission.

Conditions: Obstructive Sleep Apnea
Being tested: Ketorolac, Standard of Care
Keywords: Adenotonsillectomy, Opioids, Post-surgical pain, Anesthesiology, Pediatrics
Medical subject headings: Sleep Apnea, Obstructive, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetorolacDrug
Also called Toradol
Patients in this group will receive 0.5mg/kg of ketorolac, administered intravenously.
Standard of CareDrug
Also called Sojourn, Ultane, Diprivan, Decadron
All patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given.
A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure.
The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered.

Study groups in NCT03467750
Study group	Role	What they receive
Ketorolac	Experimental	Participants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved Receives: Drug: Ketorolac; Drug: Standard of Care
Standard of Care	Active comparator	Participants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure. Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-Anesthesia Care Unit (PACU) Morphine Requirements
The total postoperative morphine dosage required to achieve analgesia (defined as a Face, Legs, Activity, Cry, Consolability (FLACC) Scale score of less than 3) in children with obstructive sleep apnea undergoing adenotonsillectomy was compared between study arms to examine the effect of ketorolac administration.
Measured: Until PACU discharge (up to 261 minutes)

Secondary outcomes (4)

Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score
Post-Anesthesia Care Unit (PACU) nurses evaluated the patients using Face, Legs, Activity, Cry, Consolability (FLACC) Scale scores at 10 minutes post-op, 20 minutes post-op and at time of PACU discharge. Each category is scored as 0 (no indication of pain), 1 (indication of moderate pain), or 2 (visibly experiencing severe pain). Total scores range from 0 to 10, with higher scores indicating more pain.
Measured: 10 minutes post-op, 20 minutes post-op, PACU discharge (up to 261 minutes)
Post-Anesthesia Care Unit (PACU) Recovery Time
The duration of time that a participant was in the Post-Anesthesia Care Unit (PACU), following surgery, measured in minutes.
Measured: Until PACU discharge (up to 261 minutes)
Number of Participants With Post-Tonsillectomy Bleeding
Participants were monitored via medical chart review for post-tonsillectomy bleeding.
Measured: Up to 14 days after surgery
Pain Medication Administration
The total amount of pain medications administered during hospitalization was examined.
Measured: Surgery through hospital discharge (up to post-operative day 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201822 Aug 2023

First posted16 Mar 2018
Study start19 Jul 2018
Primary completion22 Aug 2023
Study completion22 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03467750
Sponsor's protocol ID: IRB00097738
Status last verified: Aug 2024
First submitted: 12 Mar 2018
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketorolac as a Strategy for Reducing Post-operative Opioid Requirements in Children With Obstructive Sleep Apnea Undergoing Adenotonsillectomy: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03467750
Acronym / sponsor ID: IRB00097738
Conditions: Obstructive Sleep Apnea
Keywords: Adenotonsillectomy, Opioids, Post-surgical pain, Anesthesiology, Pediatrics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 19 Jul 2018 (actual)
Primary completion: 22 Aug 2023 (actual)
Study completion: 22 Aug 2023 (actual)
First posted: 16 Mar 2018 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Ketorolac	Experimental	Drug: Ketorolac, Drug: Standard of CareParticipants randomized to the ketorolac group will receive 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis has been achieved
Standard of Care	Active comparator	Drug: Standard of CareParticipants randomized to this group will receive the pain management standard of care for the adenotonsillectomy procedure.

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Diagnosis of sleep disordered breathing or obstructive sleep apnea
Children undergoing elective tonsillectomy or adenotonsillectomy at Children's Healthcare of Atlanta Egleston location
Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Key exclusion criteria (3 listed)

Known coagulation defect
Patients on longstanding NSAID therapy
Known renal impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KetorolacAlso: ToradolPatients in this group will receive 0.5mg/kg of ketorolac, administered intravenously.	Drug	Ketorolac
Standard of CareAlso: Sojourn, Ultane, Diprivan, DecadronAll patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given. A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure. The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered.	Drug	Ketorolac, Standard of Care

Primary outcome

Post-Anesthesia Care Unit (PACU) Morphine Requirements
Time frame: Until PACU discharge (up to 261 minutes)
The total postoperative morphine dosage required to achieve analgesia (defined as a Face, Legs, Activity, Cry, Consolability (FLACC) Scale score of less than 3) in children with obstructive sleep apnea undergoing adenotonsillectomy was compared between study arms to examine the effect of ketorolac administration.

4 secondary outcomes

Face, Legs, Activity, Cry, Consolability (FLACC) Scale Score
Time frame: 10 minutes post-op, 20 minutes post-op, PACU discharge (up to 261 minutes)
Post-Anesthesia Care Unit (PACU) Recovery Time
Time frame: Until PACU discharge (up to 261 minutes)
Number of Participants With Post-Tonsillectomy Bleeding
Time frame: Up to 14 days after surgery
Pain Medication Administration
Time frame: Surgery through hospital discharge (up to post-operative day 2)

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketorolac	30	28
Standard of Care	33	31

Primary outcome: Post-Anesthesia Care Unit (PACU) Morphine Requirements

Time frame: Until PACU discharge (up to 261 minutes). Mean (Standard Deviation). Unit: mg/kg

Measure	Ketorolac n = 28	Standard of Care n = 31
Value	0.033 (0.034)	0.058 (0.096)

Population analysed: This analysis includes participants who completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information on adverse events was collected among participants who completed the surgery, beginning at the time of consent and continued through the final assessment at complete recovery, up to 14 days after surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketorolac	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Standard of Care	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Gilbertson, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac in people with Obstructive Sleep Apnea, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Anesthesia Care Unit (PACU) Morphine Requirements (time frame: Until PACU discharge (up to 261 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.